Bulk routes each device build through its steps in the cleanroom, logging the operator, machine, times, counts and in-process checks at every step, and a failed check opens a quality issue on the job. The build evidence is captured as the work happens, not collated from a batch folder afterwards. Order to invoice on the same record.
Bulk is medical device manufacturing software for the floor: routed build steps with operator, machine and time, in-process checks, quality issues, holds and NCRs, and material usage by job, with the order and the invoice on the same record. It is not an eQMS or PLM. It runs beside them and keeps the build evidence your ISO 13485 system relies on.
Each step of the build is completed by the operator at the station, with the machine, the times, good and reject counts and the in-process checks recorded on the job. The build record is complete when the last step is done rather than assembled from a batch folder afterwards.
Component lot refs, UDIs or batch numbers go in custom fields on the job and order, searchable and filterable in the grid, and the supplier's certificate attaches to the job as a file. The materials the job used are logged by variant with the quantity and cost. Bulk does not hold lots or serials in stock.
Bulk runs the build from the customer order to the finished device. Keep the eQMS for document control and the PLM for design. Quality issues raised on the floor carry the job, the step and the machine, and where you keep an accounts package Bulk syncs both ways with it.
Because every step, check and defect is captured as the work happens, review works from one complete job with any open quality issues and holds in front of the reviewer. The evidence for an audit is the same record, so nothing is reconstructed before the notified body or the FDA arrives.
The customer PO is read into a production order and its jobs; the component lot ref goes in a custom field and the supplier's certificate is attached.
See inbound OCR
Each step is completed by a named operator at the station, with the machine, times, counts and components logged against the job.
See production
An out-of-spec check opens a quality issue on the job; the suspect units go on a quantity hold and an NCR takes them to review.
See quality
The job carries every step, check, count and disposition, so the review works from one record and the job sheet prints from it.
See PDF templates
Bulk runs manufacturing execution on the build floor and the commercial loop an ERP usually owns: the customer order, jobs, consumable stock, invoices and credit notes, installed one app at a time. It is not a validated eQMS, so keep yours for document control, design history and complaint handling. Where you keep an accounts package, Bulk syncs both ways with it.
No, and we won't pretend otherwise. Bulk is not a validated eQMS; it will not certify your ISO 13485 QMS. What it does is run the floor so the in-process evidence behind your certification is captured at source and stays complete. Treat it as the production record under your quality system, not a replacement for it.
No. Bulk does not compile a device history record. It captures the build evidence as the work happens. Each step's operator, machine, times and counts, the in-process checks, and defects with their disposition sit on the job, and a job sheet prints from it. Your DHR draws on that record rather than a folder of travellers.
As references on the job, not in stock. Bulk records the materials each job used by variant, quantity and cost. Component lot refs, UDIs or serials go in custom fields on the job and order, searchable in the grid, and supplier certificates attach as files. It does not hold lots or serials in stock or follow a component lot through to every finished device.
Not on production steps today. Each step records the operator who completed it and the time, and the Logs tab keeps every change. Drawn signatures are captured on audits, pre-use checks and risk assessment sign-offs. Formal 21 CFR Part 11 / Annex 11 validation stays your responsibility as part of your QMS.
One per-site price with every module included (production, quality, inventory and documents in the figure), no per-module upsell, hosting and rollout included. Rollout starts with one device family end to end, customer order to finished build, proven on real batches in weeks, then the rest follow on the same pattern. Never a big-bang cutover. You can start with a free trial, no card needed.
